Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatment vortioxetine
Phase phase 4
Sponsor Lundbeck Canada Inc.
Start date February 2015
End date October 2016
Trial size 226 participants
Trial identifier NCT02332954, 15913A

Summary

The purpose of the study is to describe the association/correlation between change in patient-reported cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
vortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE
vortioxetine Trintellix
The starting and recommended dose of vortioxetine is 10 mg once daily; film-coated 10 mg tablets for oral use once daily for 52 weeks.Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.
(Other)
vortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response
vortioxetine Trintellix
The starting and recommended dose of vortioxetine is 10 mg once daily; film-coated 10 mg tablets for oral use once daily for 52 weeks.Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.

Primary Outcomes

Measure
the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)
time frame: 12 weeks

Secondary Outcomes

Measure
Cognitive function (PDQ-D-20)
time frame: 12 and 52 weeks
Cognitive function (Digit Symbol Substitution Test (DSST)
time frame: 12 and 52 weeks
Work productivity (WLQ)
time frame: 12 and 52 weeks
Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)
time frame: 12 and 52 weeks
Work productivity (World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12)
time frame: 12 and 52 weeks
Work productivity (Sheehan Disability Scale (SDS)
time frame: 12 and 52 weeks
Depressive symptoms (Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR)
time frame: 12 and 52 weeks
Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)
time frame: 12 and 52 weeks
Depressive symptoms (Clinical Global Impression-Severity (CGI-S)
time frame: 12 and 52 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - The patient is a man or woman, aged ≥18 years and <65 years (In the province of British Columbia, the patient must be aged 19 years or older in order to give Informed Consent) - The patient is engaged in volunteer work or gainful employment (working ≥20 hours per week) or is enrolled full-time in post-secondary studies or vocational training. - The patient is an outpatient consulting a Primary Care Physician or a Psychiatrist. - Patients must have a diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™) classification code 296.3x. - The current MDE is confirmed by the investigator. - The reported duration of the current MDE is at least 3 months. - The patient has a Baseline score ≥15 on the QIDS-SR. - The patient reports at least a minimal level of cognitive symptoms as defined by Baseline score of ≥30 on the PDQ-D-20. - The patient is capable of communicating with the site personnel and is able to conduct the digit-symbol substitution test (DSST). Exclusion Criteria: - The patient score is >69 on the DSST at Screening/Baseline. - The patient is, in the opinion of the investigator, not able to complete all the study assessments including, but not limited to, patient-reported assessments and the DSST. - The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features. - The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the maximum recommended dose (according to Canadian labeling). Other protocol defined inclusion and exclusion criteria do apply.

Additional Information

Official title Interventional, Open-Label, Single Cohort, Canadian Study to Describe the Relationship Between Cognitive Symptoms and Work Productivity in Working Adults Treated With Vortioxetine for Major Depressive Disorder (MDD)
Principal investigator Pratap Chokka, M.D.
Description This is an interventional, Canadian, multi-site, open-label, single cohort, flexible-dose study. The study will emulate a naturalistic real-life setting. Investigators will include Primary Care Physicians and Psychiatrists working in outpatient clinics. The study will include adult patients diagnosed with MDD according to the DSM-5™. Approximately 200 patients will be enrolled in the study. There will be approximately 100 patients who receive vortioxetine as a first treatment for the current MDE and 100 patients switched to vortioxetine due to inadequate response to their current antidepressant medication treatment. All patients will be treated with vortioxetine as per the product monograph, and at the doses determined appropriate by the investigator. The total study duration from Baseline to the end of follow-up will be approximately 56 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Lundbeck Canada Inc..